ML20010A404
| ML20010A404 | |
| Person / Time | |
|---|---|
| Site: | 07001396 |
| Issue date: | 07/10/1981 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20010A399 | List: |
| References | |
| NUDOCS 8108110396 | |
| Download: ML20010A404 (3) | |
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Appendix A NOTICE OF VIOLATION Hurley Medical Center License No. 21-00338-02 License No. 21-00338-03 License No. SNM-1393 As a result of the inspection conducted on June 23, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified:
License No. 21-00338-02 1.
10 CFR 35.14(e)(1)(i) requires each licensee who possesses sealed sou.-ces as calibration or reference sources shall perform tests for leakage and/or contamination at intervals not to exceed six months.
Contrary to this. r iuirement, a licensee representative stated the nominal 190 microcurie cesium-137 source and the nominal 283 microcurie barium-133 source has not been tested for leakage since the inception of this license.
This is a Severity Level V violation (Supplement VII).
i 2.
License Condition No. 18 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in the application dated February 8, 1978.
Part B in the above referenced application states the dose calibrator will be checked daily for constancy using calibrated cobalt-57 and cesium-137 sources.
Contrary to the above, it was determined through the NRC inspectors review of records that cobalt-57 is used daily, as required, but the cesium-137 is used at six month intervals.
This is a Severity Level V violation (Supplement VII).
3.
License Condition No. 18 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in application dated February 8, 1978.
Item 14(G) in the above referenced application states weekly r.diation surveys and wipe tests for contamination will be performed in areas where unsealed radioicotopes are used.
Contrary to the above, the required surveys and wipe tests were not performed from the middle of May,1981, to the da'y of this inspection.
This is a Severity Level V violation (Supplement VII).
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Appendix A 4.
License Condition No. 18 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in the application dated February 8, 1978.
Item 14(J) in the above referenced application states emergency rules will be posted in all areas where radioactive materials are used.
Contrary to the above, on the day of this inspection, emergency rules were not posted in the nuclear medicine laboratory where radioactive materials are used.
This is a Severity Level VI violation (Supplement VII).
License No. 21-00338-03 5.
10 CFR 35.22(a) requires spot-check measurements to be performed on each teletherapy unit at intervals not exceeding one month.
L;ntrary to this requirement, spot-checks on the theratron-80 teletherapy unit was not performed in March or April, 1981.
This is a Severity Level V violation (Supplement VII).
6.
10 CFR 20.401(a) requires each licensee to maintain records showing radiation exposure records containing all the information required by Form NRC-5.
Contrary to this requirement, the birthdates of three individuals were missing on Form NRC-5.
This is a Severity Level VI violation (Supplement VII).
7.
License Condition 20 states each teletherapy machine is to be fully inspected and serviced at intervals not to exceed five (5) years and a report of the inspection and servicing is to be kept on file for review by the Commission.
Contrary to the above, a report of the last servicing of the theratron-80 teletherapy machine was not available for review on the day of this inspection.
This is a Severity Level VI violation (Supplement VII).
License No. SNM-1393 8.
License Condition No. 16 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in the application which was transmitted by letter dated April 24, 1973.
Appendix A Item No. 7 in the letter dated April 24, 1973, states patient follow-up procedures will be conducted on a monthly basis.
Contrary to the above, a licensee representative stated patient follow-up procedures have not been conducted.
This is a Severity Level V violation (Supplement (VII).
9.
License Condition No. 14 states the licensee shall report to the Radioisotopes Licensing Branch, U.S. Nuclear Regulatory Commission, Washington, D. C. 20555, within 10 days, loss of contact with a nuclear pacemaker patient.
Contrary to the above, the licensee has been unable to contact two patients with implated Medtronic Model 9000 nuclear powered cardiac pacemakers and no report was filed with the Commission.
This is a Severity Level V violation (Supplement VII).
10.
10 CFR 19.11(a) and (b) require that current copies of Part 19, Part 20, license conditions, documents incorporated into the license, license amendments, and operating procedures be posted, or that a notice describing these documents and where they may be examined, be posted.
10 CFR 19.11(c) requires that a Form NRC 3, " Notice to Employees" be posted.
10 CFR 19.11(d) requires that these documents or notices appear in a sufficient number of places to permit individuals engaged in licensed activities to observe them.
Contrary to these requirements, on the day of this inspection, neither the documents nor the notices were posted. Moreover, the licensee did not have available a copy of License No. SNM-1393.
Pue.suant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written state-ment or explanation in reply, including for each item of noncc,mpliance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full compliance will be achieved. Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation.
Consideration may be given to extending your response time for good cause shown.
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t' Datef D. J.
ehia'wski, Chief
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